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ASPIRIN FIRST HEART ATTACK PREVENTION: LIMITED CLAIM RECOMMENDED

Executive Summary

ASPIRIN FIRST HEART ATTACK PREVENTION: LIMITED CLAIM RECOMMENDED for professional labeling by FDA's Cardio-Renal Advisory Committee on Oct. 6 by a 6-3 vote. The committee voted unanimously that the heart-attack reduction claim for aspirin should be qualified along the lines of "not for use in low-risk patients" and "for use in high-risk patients only," with the exact words describing risks to be decided at a later date. The appropriate patient population, based on committee discussion, would be males over 40 who are at significant risk of coronary heart disease, but have not yet suffered a heart attack. "My sense is . . . that there's not much enthusiasm for awarding the indication," Committee Chairman Craig Pratt, MD, Baylor University, commented. He noted "that there may be some small part of the population that will actually benefit, and that the more likely it is that the small part of the population that needs it, gets it, the higher the enthusiasm for the indication." The committee reviewer for the study, Craig Brater, MD, Indiana University, suggested that labelling "be explicit in stating that there is no decrease in total cardiovascular death . . . that there may be an increased risk of hemorrhagic stroke, that there is an increased risk of bleeding . . . and then conclude with some statement that . . . the benefit/risk ratio is probably no greater than 1 in people who are healthy with no cardiac risk."
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PS016341

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